VibrantVue Scleral Saline

VibrantVue Scleral Saline is an FDA 510(k)-cleared medical device (K201069) manufactured by Dry Eye Innovations, LLC. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 30, 2020. Regulation: 8.